At a Glance
- Tasks: Manage regulatory submissions and support innovative medicines' approval across Europe.
- Company: Leading global biotechnology organisation with a focus on innovative healthcare solutions.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative environment with diverse projects and career advancement opportunities.
- Why this job: Join a dynamic team and make a real impact on life-changing medicines.
- Qualifications: Experience in regulatory affairs and strong understanding of European regulations.
The predicted salary is between 60000 - 80000 £ per year.
Regulatory Affairs Manager EU, clinical trials, post approval Your new company An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join a leading global biotechnology organisation.
Working within the European Regulatory Affairs team, you will play a critical role in supporting the development, approval and life cycle management of innovative medicines across a diverse portfolio spanning metabolic, cardiovascular, inflammatory, endocrine and bone diseases, as well as biosimilars.
This role offers the opportunity to work on products from early clinical development through to marketing authorisation and post-approval activities, collaborating with cross-functional teams across Europe and globally.
Your new role As a key member of the Regulatory Affairs function, you will be responsible for supporting regional regulatory strategies and ensuring the successful planning and execution of regulatory submissions in line with business objectives and evolving regulatory requirements.
Key Responsibilities Plan, prepare and manage regulatory submissions, including clinical trial applications and marketing authorisation activities.
Support the implementation of regional regulatory strategies across a portfolio of development and commercial products.
Provide regulatory expertise and guidance to cross-functional teams on European regulatory requirements and pathways.
Contribute to the development of regulatory documentati...
